EXPEDIUM VIPER 196789480Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10705034295275), received between Aug 21, 2017 and Jul 30, 2025 — classified as 48 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (63 reports).

1 other recall cover devices cleared under the same FDA submission (K090648, K111136); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. IN THE SURGERY, WHEN THE ROD IN QUESTION WAS CONNECTED TO THE ROD HOLDER, IT COULD NOT CONNECT. THE NEW PRODUCT WAS OPENED AND USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663500 ↗
• MalfunctionJul 28, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION (L5-S1) FOR SPONDYLOLISTHESIS ON (B)(6)2025. DURING SURGERY, WHEN USING THE ROD IN QUESTION, THE ROD IN QUESTION COULD NOT CONNECT TO THE VIPER-PRIME ROD FOLDER. A SPARE ROD WAS USED SO THE PATIENT WAS NOT AFFECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22638468 ↗
• InjuryOct 25, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR FUSION (T9-S1) FOR SPINAL CANAL STENOSIS ON (B)(6).2014. ON (B)(6).2024, THE PATIENT UNDERWENT A SECOND SURGERY TO REMOVE THE SAI SCREW. THE SURGEON REMOVED THE SAI SCREW AS SCHEDULED. DURING SURGERY, IT WAS CONFIRMED THAT THE ROD WAS BROKEN BETWEEN L2/L3. IN ADDITION, ONE SCREW WAS CONFIRMED AS POSSIBLY LOOSE, SO THE SURGEON REPLACED IT WITH A COMBINATION OF ARTIFICIAL BONE. COCR ROD WAS USED IN THE INITIAL SURGERY, BUT TITANIUM ALLOY WAS USED IN THE SECOND SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS STABLE. THIS PC CAPTURES THE ROD BREAKAGE AND POSSIBLE SCREW LOOSENING THAT WAS FOUND DURING THE SECOND SURGERY. (B)(4) CAPTURES FROM THE FIRST SURGERY TO THE SECOND SURGERY THAT REMOVED THE SAI SCREW.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533447 ↗
• InjuryApr 3, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN POLAND AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN THAT THE PATIENT WAS OPERATED ON IN (B)(6) 2020 IN MID (B)(6) THIS YEAR SHE CAME TO US WITH PAIN IN THE OPERATED AREA. A BROKEN ROD HAS BEEN FOUND IN THE X-RAY. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 19032744 ↗
• InjuryJun 8, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS PC IS RELATED TO (B)(4), AND (B)(4). THIS PC REPORTS ABOUT THE BACK PAIN AND BREAKAGE OF THE RODS OCCURRED AFTER THE VCR PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT AFTER THE VCR, WHEN THE PATIENT TWISTED HIS/HER BACK TO GET SOMETHING FROM THE REFRIGERATOR ON (B)(6) 2023. HE/SHE BEGAN TO HAVE BACK PAIN, WHICH GRADUALLY WORSENED. ON (B)(6) 2023, THE PATIENT WAS EXAMINED AND FOUND THAT THE BILATERAL RODS INSTALLED IN 5/S WERE BROKEN. ON (B)(6) 2023, A REOPERATION WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 17088328 ↗
• InjuryJun 8, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS PC IS RELATED TO (B)(4) AND (B)(4). THIS PC REPORTS ABOUT THE BACK PAIN AND BREAKAGE OF THE RODS OCCURRED AFTER THE VCR PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT AFTER THE VCR, WHEN THE PATIENT TWISTED HIS/HER BACK TO GET SOMETHING FROM THE REFRIGERATOR ON (B)(6) 2023, HE/SHE BEGAN TO HAVE BACK PAIN, WHICH GRADUALLY WORSENED. ON (B)(6) 2023, THE PATIENT WAS EXAMINED AND FOUND THAT THE BILATERAL RODS INSTALLED IN 5/S WERE BROKEN. ON (B)(6) 2023, A REOPERATION WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 17088321 ↗
• MalfunctionFeb 8, 2023Break; Break

  IT WAS REPORTED THAT THE VIPER2 STRAIGHT ROD480MM COCR SNAPPED DURING IN-SITU BENDING. 199721000 _ CORRECTION KEYS X 2 THREADS OF SET SCREWS WERE SHEARED BY BLUNT TIP OF DRIVER. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328484 ↗
• InjuryAug 31, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: ON (B)(6) 2022, THE PATIENT UNDERWENT A PRIMARY FUSION AND A CORRECTION PROCEDURE (T2-S2) FOR TREATING ADULT SPINAL DEFORMITY. ON APR. 27 THE PATIENT UNDERWENT A SECONDARY PROCEDURE (PSO AT L4). A STRYKER¿S CONNECTOR(S) WAS DEPLOYED WITH THE RODS IN QUESTION. ON AUG. 5 IT WAS FOUND THAT THE RODS HAD BROKEN OFF. ALSO, BONE FUSION WAS NOT OBTAINED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON THE SAME DAY. THE SURGEON MADE THE FOLLOWING COMMENT: 1. NO FURTHER INFORMATION IS AVAILABLE WHY THE BONE FUSION WAS NOT ACHIEVED. IT MIGHT HAVE BEEN TRIGGERED BY A LOOSE STRYKER¿S CONNECTOR AND/OR THE RODS¿ BREAKAGES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15331172 ↗
• InjuryAug 31, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2022, THE PATIENT UNDERWENT A PRIMARY FUSION AND A CORRECTION PROCEDURE (T2-S2) FOR TREATING ADULT SPINAL DEFORMITY. ON APR. 27 THE PATIENT UNDERWENT A SECONDARY PROCEDURE (PSO AT L4). A STRYKER¿S CONNECTOR(S) WAS DEPLOYED WITH THE RODS IN QUESTION. ON AUG. 5 IT WAS FOUND THAT THE RODS HAD BROKEN OFF. ALSO, BONE FUSION WAS NOT OBTAINED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON THE SAME DAY. THE SURGEON MADE THE FOLLOWING COMMENT: NO FURTHER INFORMATION IS AVAILABLE WHY THE BONE FUSION WAS NOT ACHIEVED. IT MIGHT HAVE BEEN TRIGGERED BY A LOOSE STRYKER¿S CONNECTOR AND/OR THE RODS¿ BREAKAGES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15331063 ↗
• MalfunctionAug 26, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE COBALT CHROME ROD SNAPPED UNDER VERY LIGHT TENSION WHILE DOCTOR WAS USING THE FRENCH BENDER TO ADD KYPHOSIS TO THE ROD. SURGEON REQUESTED A MATERIAL TEST BE PERFORMED ON THE ROD. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303060 ↗
• InjuryFeb 16, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON, (B)(6) 2020 THE PATIENT UNDERWENT THE PRIMARY POSTERIOR SPINAL FUSION(PSF) PROCEDURE (TH9~SAI) FOR TREATING ASD. ON (B)(6) 2022, THE ROD AT SAI LEFT WAS BACKED OUT AND THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE ON THE SAME DAY. THIS EVENT INVOLVES PREVIOUSLY REPORTED UNDER (B)(4). THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13544699 ↗
• MalfunctionDec 29, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE PATIENT UNDERWENT A DEFORMITY CORRECTION SURGERY. DURING THE ROD CONTOURING THE STAINLESS-STEEL ROD BROKE IN-SITU CAUSING A FORTY-FIVE (45) MINUTE DELAY IN THE COMPLETION OF THE SURGERY. THERE WERE NO FRAGMENTS GENERATED. THE ROD BROKE AS LARGER PIECES, AND IT WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY BY USING A TITANIUM ROD INSTEAD. REPORTEDLY THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR A ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13108915 ↗
• InjuryDec 9, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE AFTER (B)(6) 2021, IT WAS FOUND THAT THE RODS WHICH WERE DEPLOYED AT T11 LOWER LEFT AND RIGHT HAD BROKEN OFF. ON (B)(6) 2021, THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS IS STABLE. THE PATIENT HAD THIRD SPINAL FUSION (T11) SURGERY FOR TUMOR AND WENT FOR REVISION SURGERY ON (B)(6) 2021. CONCOMITANT DEVICE REPORTED. UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN). UNKNOWN SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 1 OF 2 OR COMPLAINT (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12968324 ↗
• InjuryDec 9, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE AFTER (B)(6) 2021, IT WAS FOUND THAT THE RODS WHICH WERE DEPLOYED AT T11 LOWER LEFT AND RIGHT HAD BROKEN OFF. ON (B)(6) 2021, THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS IS STABLE. THE PATIENT HAD THIRD SPINAL FUSION (T11) SURGERY FOR TUMOR AND WENT FOR REVISION SURGERY ON (B)(6) 2021. CONCOMITANT DEVICE REPORTED. UNKNOWN SCREWS (PART# UNKNOWN, LOT # UNKNOWN), UNKNOWN SET SCREWS (PART# UNKNOWN, LOT # UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 2 OF 2 OR COMPLAINT (B)(4), RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12968322 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE VIPER2 STRAIGHT ROD480MM, COCR WAS DISCOVERED BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844079 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(6). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ROD, STRAIGHT 5.5 X 480MM. THIS IS REPORT 8 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816615 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ROD, STRAIGHT 5.5 X 480MM. THIS IS REPORT 6 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816594 ↗
• MalfunctionAug 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE REFERENCE BLACK LINE IS NOT ALIGNED WITH THE HEX TIP. THE ROD HOLDER IS NOT ALIGNED WITH THE BLACK LINE OF THE ROD AND FOR DEFORMITY CASES IT IS NOT APPRECIATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 480MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316528 ↗
• MalfunctionApr 30, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE UNIVERSAL CONNECTOR CAP THREAD WAS OUT WHEN SURGEON CLOSED THE CAP AND THE CAP DRIVER SHAFT WAS WORN AWAY. THE ROD WAS BROKEN WHEN THE SURGEON USED THE IN-SITU BENDER. THERE WAS NO FRAGMENT GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 20-MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS REPORT IS 1 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753763 ↗
• InjuryDec 30, 2020Break; Break

  CONCOMITANT DEVICE REPORTED: RODS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 2), SCREWS (PART# NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 11).

  Patient problems: Failure of Implant

  MAUDE report 11096923 ↗
• MalfunctionSep 13, 2020Break; Break

  PROCEDURE WAS COMPLETED WITH A TEN (10) MINUTE DELAY. THE SURGEON HAD TO ORGANIZE ANOTHER ROOT. THE SURGEON COMMENTED THAT: THE ROOT WAS BENT 2-3 TIMES AT DIFFERENT PLACES TO ATTEND THE RIGHT KYPHOSIS. THE APPROXIMATE ANGLE DURING THE BENDING (UNTIL THE BREAK) WAS NOT MORE THEN 10 DEGREES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10526263 ↗
• MalfunctionAug 7, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A SURGERY ON (B)(6) 2020 THE SURGEON WAS BENDING THE ROD ABOUT 10 CM INTO THE EDGE OF THE ROD. THE ROD BROKE DURING BENDING. A SECOND ROD BROKE IN THE SAME MANNER. A SURGICAL DELAY OF 20 MINUTES WAS REPORTED. PATIENT STATUS WAS REPORTED AS GOOD. CONCOMITANT DEVICE REPORTED: SAGITTAL IN-SITU BENDER, LEFT (PART # 299704195, LOT # UNKNOWN, QUANTITY # 1). SAGITTAL IN-SITU BENDER, RIGHT,(PART # 299704200, LOT # UNKNOWN, QUANTITY # 1). FRENCH ROD BENDER (PART # 299704170, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381495 ↗
• MalfunctionAug 7, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A SURGERY ON (B)(6) 2020 THE SURGEON WAS BENDING THE ROD ABOUT 10 CM INTO THE EDGE OF THE ROD. THE ROD BROKE DURING BENDING. A SECOND ROD BROKE IN THE SAME MANNER. A SURGICAL DELAY OF 20 MINUTES WAS REPORTED. PATIENT STATUS WAS REPORTED AS GOOD. CONCOMITANT DEVICE REPORTED: SAGITTAL IN-SITU BENDER, LEFT (PART # 299704195, LOT # UNKNOWN, QUANTITY # 1). SAGITTAL IN-SITU BENDER, RIGHT,(PART # 299704200, LOT # UNKNOWN, QUANTITY # 1). FRENCH ROD BENDER (PART # 299704170, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381322 ↗
• MalfunctionJul 31, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN SURGERY THAT THE ROD BROKE DUE TO EXTREME BENDING WITH THE BENDING IRONS. NO FRAGMENTS WERE GENERATED. THE BROKEN ROD WAS REPLACED WITH A NEW ONE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: BENDER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10349934 ↗
• InjuryJul 9, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, ON (B)(6) 2018 AN INITIAL SPINAL FUSION WITH EXPEDIUM SYSTEM WAS PERFORMED TREATING KYPHOSIS. THE ROD WAS IMPLANTED BETWEEN STRYKER¿S CONNECTORS WITHOUT SURGICAL DELAY. ON (B)(6) IT WAS REPORTED THAT THE ROD WAS BROKEN, AND THE BREAKAGE WAS LOCATED BENEATH THE TRANSVERSE ROD CONNECTOR IN L3. PSEUDO ARTICULATION WAS CONFIRMED, TOO. ON (B)(6) A REVISION PROCEDURE SUCCEEDED. THE ROD IN QUESTION, THE TRANSVERSE ROD CONNECTOR AND THE STRYKER¿S CONNECTORS WERE REMOVED, AND REPLACEMENTS WERE DEPLOYED WITHOUT ANY ISSUE. THE PATIENT IS HOSPITALIZED AND STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN MON 5.5MM TRC W/BODY, 40MM (PART# 177440040, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10252771 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090648, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467