OVERWATCHRecalls & reported problems across all models
Spinal Elements · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 10 models of OVERWATCH by Spinal Elements in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2019 and Aug 13, 2026 — classified as 9 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (20 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OVERWATCH problems
Device problems
- Mechanical Problem20
- Fracture18
- Detachment of Device or Device Component2
- Unintended Movement1
- Unintended System Motion1
Patient problems
- Failure of Implant13
- Foreign Body In Patient4
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
- Pain1
- Vertebral Fracture1
OVERWATCH models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OVERWATCH 108-ET-6540CThoracolumbosacral Pedicle Screw System7 reports
- OVERWATCH 108-107-01-SOrthopedic Manual Surgical Instrument5 reports
- OVERWATCH 108-SSThoracolumbosacral Pedicle Screw System2 reports
- OVERWATCH 108-L-6540Thoracolumbosacral Pedicle Screw System1 report
- OVERWATCH 108-L-8580Thoracolumbosacral Pedicle Screw System1 report
- OVERWATCH 108-L-6550CThoracolumbosacral Pedicle Screw System1 report
- OVERWATCH 108-ET-6550CThoracolumbosacral Pedicle Screw System1 report
- OVERWATCH 108-107-01-SCScrewdriver1 report
- OVERWATCH 108-157-01Orthopedic Stereotaxic Instrument1 report
- OVERWATCH 108-104-45Orthopedic Manual Surgical Instrument1 report
Recent OVERWATCH adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Mechanical Problem; Detachment of Device or Device Component
Patient problems: Failure of Implant
MAUDE report 50242592 ↗MalfunctionMay 8, 2026Fracture; Mechanical Problem
ON (B)(6) 2026 PATIENT UNDERWENT REVISION SURGERY TO REMOVE HARDWARE FOR SPINAL FUSION SURGERY FOR ADJACENT SEGMENT DISEASE AFTER SUCCESSFUL FUSION HAD OCCURRED AT INDEX LEVEL. REPORTEDLY DUE TO THE PATIENT'S SCLEROTIC BONE AND BONE INGROWTH, THE BONE SCREW WAS FUSED TO THE BONE. INTRA-OPERATIVELY EXCESSIVE FORCE WAS USE AND THE BONE SCREWDRIVER DEVICE FRACTURED AT THE TIP. THE SURGEON ELECTED TO LEAVE THE BONE SCREW AND THE DEVICE TIP ENCASED IN THE SCREW HEAD AND COMPLETED THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25124977 ↗MalfunctionMar 25, 2026Fracture; Mechanical Problem
ON (B)(6) 2026 PATIENT UNDERWENT NINE LEVEL POSTERIOR SPINAL FIXATION SURGERY. REPORTEDLY DUE TO THE PATIENT'S SCLEROTIC BONE AN UNDER SIZE 4.5MM BONE TAP WAS USE TO INITIATE THE OSTEOTOMY. INTRA-OPERATIVELY THE BONE TAP DEVICE FRACTURED AT THE TIP. THE SURGEON ELECTED TO LEAVE THE DEVICE TIP ENCASED IN BONE AND COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24694367 ↗MalfunctionMar 26, 2024Fracture; Mechanical Problem; Fracture; Mechanical Problem
PATIENT UNDERWENT TLIFSPINAL FUSION SURGERY AT L2-L5 ON (B)(6) 2023. ON (B)(6) 2024 IT WAS REPORTED THAT THE RIGHT L5 BONE SCREW WAS FRACTURED. THERE IS NO PLAN TO REVISE THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 18980377 ↗MalfunctionDec 15, 2023Unintended System Motion; Unintended Movement; Unintended System Motion; Unintended Movement
REPORTEDLY DURING A TLIF SPINAL FUSION SURGERY WITH POSTERIOR FIXATION (L2- S1), A PEDICLE BONE SCREW FRACTURED/CRACKED THE PEDICLE BONE L3 ON (B)(6) 2023. ALLEGEDLY THE DRIVER OR DRIVER SLEEVE WAS BENT. THE DEVICE WOBBLED AND HAD A DIFFERENT TRAJECTORY AND/OR DIFFERENT STARTING POINT, WHEN ADVANCING THE SCREW. THIS CONDITION ALLEGED CAUSED A CRACKED/FRACTURE IN THE PEDICLE BONE. NO ADDITIONAL MEDICAL INTERVENTION WAS TAKEN. PATIENT IS ASYMPTOMATIC AND THERE IS NO PLAN FOR REVISION SURGERY.
Patient problems: Vertebral Fracture
MAUDE report 18340772 ↗InjuryNov 30, 2022Fracture; Mechanical Problem; Fracture; Mechanical Problem
PATIENT UNDERWENT SPINAL FUSION SURGERY AT L5-S1 CIRCA 2019. ON (B)(6) 2022 IT WAS REPORTED THAT BOTH S1 BONE SCREWS WERE FRACTURED. REVISION SURGERY OCCURRED ON (B)(6) 2022 AND BOTH SCREWS WERE SUCCESSFULLY REPLACED.
Patient problems: Failure of Implant
MAUDE report 15889657 ↗InjuryMar 3, 2022Fracture; Mechanical Problem; Fracture; Mechanical Problem
AS PART OF A RETROSPECTIVE REVIEW SPANNING 2019-2021 GIVEN BY AN ORTHOPEDIC MEDICAL GROUP, IT WAS REPORTED THAT A PATIENT RECEIVED A PLF WITH BILATERAL POSTERIOR FIXATION FROM L5-S1. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. PHOTOGRAPH WAS PROVIDED OF ONE OF THE S1 BONE SCREWS THAT FRACTURED. NO INITIAL SURGERY INFORMATION, PATIENT INFORMATION OR EVENT INFORMATION WERE PROVIDED.
Patient problems: Failure of Implant
MAUDE report 13660969 ↗InjuryMar 3, 2022Fracture; Mechanical Problem; Fracture; Mechanical Problem
AS PART OF A RETROSPECTIVE REVIEW SPANNING 2019-2021 GIVEN BY AN ORTHOPEDIC MEDICAL GROUP, IT WAS REPORTED THAT A PATIENT RECEIVED A PLF WITH BILATERAL POSTERIOR FIXATION FROM L5-S1. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. PHOTOGRAPH WAS PROVIDED OF ONE OF THE S1 BONE SCREWS THAT FRACTURED. NO INITIAL SURGERY INFORMATION, PATIENT INFORMATION OR EVENT INFORMATION WERE PROVIDED.
Patient problems: Failure of Implant
MAUDE report 13660962 ↗InjuryFeb 17, 2022Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
PATIENT UNDERWENT PLIF SPINAL FUSION SURGERY (L5-S1) ON (B)(6) 2021 TO CORRECT GRADE 3 SPONDYLOLISTHESIS AND PAIN. TWO WEEKS POST OPERATIVELY IT WAS DISCOVERED THAT THE LEFT L5 LOCK SCREW HAD LOOSENED. REVISION SURGERY TO REPLACE THE SCREW WITH A LARGER SCREW OCCURRED ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 13549446 ↗InjuryNov 11, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem
AS PART OF A RETROSPECTIVE REVIEW PRESENTATION SPANNING 2019-2021 GIVEN BY AN ORTHOPEDIC MEDICAL GROUP, IT WAS NOTED THAT A PATIENT RECEIVED A PLF WITH BILATERAL POSTERIOR FIXATION FROM L5- S1 ON (B)(6) 2020. ONE YEAR POST OPERATIVELY REPORTED THE S1 BONE SCREW(S) HAD FRACTURED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.
Patient problems: Failure of Implant
MAUDE report 12801211 ↗MalfunctionNov 11, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem
AS PART OF A RETROSPECTIVE REVIEW PRESENTATION SPANNING 2019-2021 GIVEN BY AN ORTHOPEDIC MEDICAL GROUP, IT WAS NOTED THAT A PATIENT RECEIVED A PLF WITH BILATERAL POSTERIOR FIXATION FROM L4- S1 ON (B)(6) 2021. TWO MONTHS POST OPERATIVELY ((B)(6) 2021) RADIOGRAPHS DEPICTED THE LEFT S1 BONE SCREW HAD FRACTURED. PLAN FOR REVISION SURGERY IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 12801086 ↗InjuryNov 11, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem
AS PART OF A RETROSPECTIVE REVIEW PRESENTATION SPANNING 2019-2021 GIVEN BY AN ORTHOPEDIC MEDICAL GROUP, IT WAS NOTED THAT A PATIENT RECEIVED A PLF WITH BILATERAL POSTERIOR FIXATION FROM L5- S1 ON (B)(6) 2021. TWO MONTHS POST OPERATIVELY ((B)(6) 2021) RADIOGRAPHS DEPICTED THE LEFT S1 BONE SCREW HAD FRACTURED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.
Patient problems: Failure of Implant
MAUDE report 12801075 ↗InjuryNov 7, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem
ON (B)(6) 2021 PATIENT RECEIVED BILATERAL POSTERIOR FIXATION PLF FROM L5- S1. THREE MONTH POST OPERATIVELY RADIOGRAPH DEPICTED BOTH SCREWS AT S1 WERE FRACTURED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.
Patient problems: Failure of Implant
MAUDE report 12763462 ↗MalfunctionOct 12, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem
WHILE DRIVING THE PEDICLE BONE SCREW, REPORTEDLY THE DRIVER TIP FRACTURED AND REMAINED IN THE HEAD OF THE SCREW SHANK. THOUGH THE DRIVER TIP WAS IDENTIFIED, THE SURGEON ELECTED TO LEAVE THE DRIVER TIP AND THE SCREW IN PLACE. NO INJURY TO THE PATIENT WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 12619060 ↗MalfunctionOct 12, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem
WHILE DRIVING THE PEDICLE BONE SCREW, REPORTEDLY THE DRIVER TIP FRACTURED AND REMAINED IN THE HEAD OF THE SCREW SHANK. THOUGH THE DRIVER TIP WAS IDENTIFIED, THE SURGEON ELECTED TO LEAVE THE DRIVER TIP AND THE SCREW IN PLACE. NO INJURY TO THE PATIENT WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 12619010 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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