MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-04-01 for MOD BENDER TIP-A, 5.5MM, 10DEG 698335326 manufactured by Depuy Spine Inc.
[142784745]
(b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. 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
[142784746]
It was reported that dr. (b)(6) was performing a posterior spinal fusion (scoliosis fusion) on a (b)(6) y. Old male patient. While doing final tightening the x25 torque drive shafts stripped at the distal end of the shaft. This is probably due to normal wear and tear, both shafts present in the set need to be replaced. As well, while dr. (b)(6) was correcting the lordosis of the spinal curve through the rod, one of the attachment 10 degree angle prong broke off where it attaches to the l bender. (this device is a custom device and i am not certain if it is registered with depuy synthes, however it is made by depuy synthes). This occurred on the left bender (698335318) and the attachment piece is (698335326). Nothing fell into the patient. The surgeon was able to complete the surgery without delay and without complications. I have nothing further to add to this complaint. The broken shafts will be sent via purolator (tracking: (b)(4). The l bender and the attachment are currently not available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51500 |
| MDR Report Key | 8470798 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-01 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-04-01 |
| 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 | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SPINE INC |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOD BENDER TIP-A, 5.5MM, 10DEG |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2019-04-01 |
| Model Number | 698335326 |
| Catalog Number | 698335326 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE INC |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-01 |