UNKNOWN SCREWS
Report
- Report Number
- 0008031020-2022-00386
- Event Type
- Injury
- Date Received
- August 10, 2022
- Date of Event
- December 22, 2021
- Report Date
- September 25, 2022
- Manufacturer
- STRYKER GMBH
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT REGARDING SCREW BREAKAGE AND ADDITIONAL LOOSENING COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, RADIOGRAPHS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.
THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING THE POST-MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT OF SCREW BREAKAGE AND ADDITIONAL LOOSENING AFTER 8 MONTHS OF SURGERY COULD BE CONFIRMED, FROM THE AVAILABLE RADIOGRAPHS IN THE LITERATURE. BASED ON THE AVAILABLE INFORMATION AND THE AVAILABLE X-RAY A FORMAL MEDICAL OPINION WAS SORT THE DORSAL SCREW POSITIONING IS CORRECT AND SEEMS TO BE THE CORRECT CHOICE. WITH THE IMPLANTATION OF THE EXTERNAL FIXATEUR IN ADDITION TO THE PLATE TO ASSURE THE FRACTURE REDUCTION FOR 6 WEEKS ALL NECESSARY MEASUREMENTS HAVE BEEN TAKEN TO ASSURE THE FRACTURE FIXATION. THERE ARE NO OBVIOUS SURGICAL MISTAKES VISIBLE IN THE PROVIDED X-RAY AND THUS IT REMAINS A LITTLE UNCLEAR WHY THE LOSS OF FIXATION APPEARED ALTHOUGH THE FRACTURE REDUCTION WAS ASSURED BY THE EXTERNAL FIXATEUR. THE REASON BEHIND THE ALLEGED FAILURE IS MOST LIKELY THE EXTENSIVE BONY AND LIGAMENTOUS INJURY HAVE LED TO A HIGH INSTABILITY OF THE PELVIC RING INCREASING THE RISK OF A LOSS OF FIXATION. FROM THE MEDICAL OPINION THE PRIMARY ROOT CAUSE CAN BE ATTRIBUTED TO AS PATIENT RELATED FACTOR. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.
THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPAEDIC SURGERY, CHUNGBUK NATIONAL UNIVERSITY HOSPITAL, KOREA¿. THE TITLE OF THIS REPORT IS ¿DELAYED BLADDER PERFORATION DUE TO SCREW LOOSENING AFTER PELVIC RING INJURY SURGERY¿, PUBLISHED ON DECEMBER 22, 2021, AND CAN BE FOUND AT HTTPS://DOI.ORG/10.20408/JTI.2021.0054. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿MATTA PELVIC SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 1 PATIENT. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A PRECISE DEVICE(S) IDENTIFICATION OR PATIENT INFORMATION; HOWEVER, THE ARTICLE ALLEGES THAT 1 PATIENT EXPERIENCED SCREW BREAKAGE AND ADDITIONAL LOOSENING AFTER 8 MONTHS OF SURGERY.
THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPAEDIC SURGERY, CHUNGBUK NATIONAL UNIVERSITY HOSPITAL, KOREA¿. THE TITLE OF THIS REPORT IS ¿DELAYED BLADDER PERFORATION DUE TO SCREW LOOSENING AFTER PELVIC RING INJURY SURGERY¿, PUBLISHED ON DECEMBER 22, 2021, AND CAN BE FOUND AT HTTPS://DOI.ORG/10.20408/JTI.2021.0054. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿MATTA PELVIC SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 1 PATIENT. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A PRECISE DEVICE(S) IDENTIFICATION OR PATIENT INFORMATION; HOWEVER, THE ARTICLE ALLEGES THAT 1 PATIENT EXPERIENCED SCREW BREAKAGE AND ADDITIONAL LOOSENING AFTER 8 MONTHS OF SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1522434 | UNKNOWN SCREWS | SCREW, FIXATION, BONE | HWC | STRYKER GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |