OVERWATCH 108-ET-6540CRecalls & reported problems
Spinal Elements · OVERWATCH® 6.5MM x 40MM MIS POLY EXTENDED TAB CANNULATED SCREW · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840916131852), received between Nov 7, 2021 and Nov 30, 2022 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (7 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture7
- Mechanical Problem7
Patient problems
- Failure of Implant7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
Other Thoracolumbosacral Pedicle Screw System devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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