MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-22 for 3.5MM TI LCP? METAPHYSEAL PLATE 12 HOLES 423.412S manufactured by Oberdorf Synthes Produktions Gmbh.
[155955839]
Complainant part is not expected to be returned for manufacturer review/investigation. Part: 423. 412s; lot: l980401; manufacturing site: (b)(4). Release to warehouse date: july 27, 2018. Expiry date: july 01, 2028. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. Product was not returned. Based on the information available, it has been determined that no corrective and 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. (b)(4). 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 Sequence No: 1, Text Type: N, H10
[155955840]
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, the patient underwent a malignant tumor removal surgery for femoral fracture with pediatric hip plate and metaphyseal plate with 12 holes (first plate). On (b)(6) 2019, the metaphyseal plate was replaced with another metaphyseal plate with 14 holes (second plate) because the initial plate had broken. On (b)(6) 2019, the second metaphyseal plate was replaced with a new plate because the second plate had broken as well. Concomitant devices: locking screws (part: unknown, lot: unknown, quantity: unknown). This report is for a 3. 5mm titanium (ti) locking compression plate (lcp)? Metaphyseal plate 12 holes. This is report 1 of 1 for (b)(6) and captures the breakage of the first metaphyseal plate. Related (b)(6) captures the breakage of the second plate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-67650 |
| MDR Report Key | 8922616 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-22 |
| Date of Report | 2019-07-25 |
| Date Mfgr Received | 2019-07-25 |
| Device Manufacturer Date | 2018-07-27 |
| Date Added to Maude | 2019-08-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK GRENCHEN (CH) |
| Manufacturer Street | SOLOTHURNSTRASSE 186 |
| Manufacturer City | GRENCHEN 2540 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2540 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM TI LCP? METAPHYSEAL PLATE 12 HOLES |
| Generic Name | APPLIANCES, FIXATION, NAIL/BLD/PL COMBO, MULTI COMP, METAL COM |
| Product Code | LXT |
| Date Received | 2019-08-22 |
| Catalog Number | 423.412S |
| Lot Number | L980401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-22 |