TI LOW PROF NEURO CONTOUR MESH 200MM X 200MM/0.6MM RIGID
Report
- Report Number
- 8030965-2018-55738
- Event Type
- Injury
- Date Received
- August 15, 2018
- Report Date
- July 31, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- JEY
- UDI-DI
- 07611819753785
- PMA / PMN Number
- K022012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE HISTORY LOT PART NUMBER: 421.535 SYNTHES LOT NUMBER: 7904638 RELEASE TO WAREHOUSE DATE: 05-MAY-2015 MANUFACTURING SITE: SYNTHES MONUMENT NO NCRS WERE GENERATED DURING PRODUCTION. DHR REVIEW: THE RETURNED DEVICE WAS MANUFACTURED IN MAY 2015. NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY (CQ) CONFIRMED THE CONDITION OF POST OPERATIVE BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. A LARGE "L" SHAPED BREAK EXISTS ON THE MESH. ONE SMALL BROKEN OFF SECTION WAS ALSO RETURNED. THE MESH WAS MODIFIED (CONTOURED) TO FIT CRANIAL ANATOMY. A DEFINITIVE ROOT CAUSE FOR THE RETURNED MESH BREAKING POST OPERATIVELY COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE MESH WAS CONTOURED TO FIT CRANIAL ANATOMY, THEREFORE IT IS POSSIBLE THAT A REVERSE BEND OCCURRED DURING CONTOURING/IMPLANTATION WEAKENING THE MESH ON A BEND LINE WHICH CONTRIBUTED TO THE MESH ULTIMATELY BREAKING. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION AND THE COMPLAINT CONDITION IS ADEQUATELY COVERED BY THE RISK ASSESSMENT. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE RETURNED MESH BREAKING POST OPERATIVELY COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE MESH WAS CONTOURED TO FIT CRANIAL ANATOMY, THEREFORE IT IS POSSIBLE THAT A REVERSE BEND OCCURRED DURING CONTOURING/IMPLANTATION WEAKENING THE MESH ON A BEND LINE WHICH CONTRIBUTED TO THE MESH ULTIMATELY BREAKING. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION AND THE COMPLAINT CONDITION IS ADEQUATELY COVERED BY THE RISK ASSESSMENT. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PART: 421.535; SYNTHES LOT: 7904638; RELEASE TO WAREHOUSE DATE: MAY 05, 2015; MANUFACTURING SITE: SYNTHES (B)(4); NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PATIENT WEIGHT IS UNKNOWN. DEVICE BROKE ON AN UNKNOWN DATE BETWEEN (B)(6) 2016 AND (B)(6) 2018. DATE OF EXPLANTATION IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER EMAIL ADDRESS IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT CRANIOPLASTY ON (B)(6) 2016, WHEREIN THE TITANIUM (TI) LOW PROFILE NEURO CONTOURABLE MESH RIGID PLATE WAS IMPLANTED. ON (B)(6) 2018, THE PATIENT RETURNED TO THE HOSPITAL AFTER FEELING PAIN. AN X-RAY WAS TAKEN AND INDICATED THAT THE PLATE HAD BROKEN. REVISION SURGERY WAS DONE, AND THE BROKEN PLATE WAS REPLACED WITH A NEW UNKNOWN DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT CONDITION IS NOW STABLE. CONCOMITANT DEVICES: LOW PROFILE NEURO SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A TI LOW PROF NEURO CONTOUR MESH 200MM X 200MM/0.6MM RIGID. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 628009 | TI LOW PROF NEURO CONTOUR MESH 200MM X 200MM/0.6MM RIGID | BONE PLATE | JEY | OBERDORF SYNTHES PRODUKTIONS GMBH | 7904638 | 07611819753785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention | THERAPY DATE: APRIL 22, 2016| SEE DESCRIPTION, THERAPY DATE: (B)(4) 2016 |